SchizophreniaPhase 4CARE IINCT00681629
Schizophrenic Patients in Integrated Care
A Phase 4 study testing Quetiapine XR and Integrated Care Program (ICP) in people with Schizophrenia and Schizoaffective Disorder, run by AstraZeneca at 8 sites in Germany.
Trial summary
The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- What is being tested?
- Quetiapine XR and Integrated Care Program (ICP)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 8 sitesGermany
- Study dates
- Jul 2008to Nov 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with baseline SWN-K <=70
- Provision of signed informed consent
- Out-patients with schizophrenia, schizophreniform disorder or schizoaffective disorder, severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points
Who cannot join
- Evidence of a clinical relevant disease, eg renal or hepatic impairment, significant coronary heart disease, hepatitis B or C, AIDS
- Patients with known cardiovascular disease or other condition predisposing to hypotension or family history of QT prolongation
- Patients who pose an imminent risk of suicide or danger to self or others
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Research Site
Berlin, State of Berlin
Research Site
Chemnitz, Saxony
Research Site
Hamburg, Free and Hanseatic City of Hamburg
Research Site
Lüneburg, Lower Saxony
Research Site
München, Bavaria
Research Site
Oldenburg, Lower Saxony
Research Site
Oranienburg, Brandenburg
Research Site
Stolberg
About this study
Official title: CARE II - Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Phase IV Study
The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month
- Being tested
- Quetiapine XR, Integrated Care Program (ICP)
- Keywords
- Schizophrenia, Integrated Care, Quetiapine
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine XRDrug
Also called Seroquel Prolong
400-800 mg, oral, bid
Integrated Care Program (ICP)Other
Integrated care program (ICP), this is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine XR Alone | Experimental | Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion Receives: Drug: Quetiapine XR |
| Quetiapine XR With Integrated Care Program (ICP) | Experimental | Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion Receives: Drug: Quetiapine XR; Other: Integrated Care Program (ICP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale
The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.
Measured: 4 months
Secondary outcomes (19)
Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score
The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.
Measured: 4 month
Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale
With the CGI-S the rate of the severity of a patient's symptoms (positive, negative, cognitive, depressive and overall) using a scale ranging from 1 (normal, not ill) to 7 (among the most severely ill) is measured - higher scores implying higher severity.
Measured: 4 month
Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score
The schizophrenic symptomatology will be measured by the Positive and Negative Syndrome Scale (PANSS) providing 8 items of which each is rated on a severity scale ranging from 1-7, (1= absent - 7 = extreme severe. higher scores implying higher severity.
Measured: 4 month
GAF (Global Assessment of Functioning) Scale Score
The "GAF" is a numeric rating scale used by clinicians for assessment of the social, occupational, psychological functioning of adult patients. The scale represents a hypothetical continuum of mental health illness providing a descending scoring code from 100 until 0. Higher scores indicate better patient condition and performance.
Measured: 4 month
PSP (Personal and Social Performance) Scale Score
The '(PSP" rating scale (100 until 0) used by clinicians for assessment of 4 main domains of functioning in adult patients acc. (a) socially useful activities including work and study, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behavior. Higher scores indicate better patient condition and performance.
Measured: 4 month
EQ-5D (European Quality of Life Questionnaire) Score
The EQ-5D questionnaire is a generic measure of health status. It defines health in terms of five dimensions:1 (Mobility); 2 (Self-care); 3 (Usual activity); 4 (Pain/Discomfort); 5 (Anxiety/Depression).
The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Each dimension has 3 levels of "severity"- "no problems, "some problems" and "extreme problems". Higher scores indicate more problems.
Measured: 4 month
Vocational Occupational Index "VOC" Score
The "VOC" index will assess the following 7 items: 1 fulltime gainful employment, 2 homemaker or student, 3 part-time gainful employment (20 hours per week or less), 4 retired, 5 full or part-time volunteer, 6 on medical or psychiatric leave of absence, 7 unemployed, whether or not expected to work. Results will be descriptively summarized. The VOC index will be completed at each visit. Difference from baseline of the index will be derived at each assessment
Measured: Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18)
Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire
Q-LES-Q-18 will allow to generate a general QoL-index which will be used for the analysis and is defined as the average of the single scores for all 18 items. Scoring will be carried out from 1-5 per item (never / rarely / sometimes / frequently / all the time). Results will be descriptively summarized.
Measured: 4 month
Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale
The '(RSM" is a new 36-item measure validated to assess the "QoL" in different dimensions of schizophrenic patient treated with antipsychotics. It will be rated on a four-point Likert scale (not / rather not / rather yes / yes) by the patient and the investigator. The total score ranges from min. 0 to max. of 108. Higher scores indicate higher "QoL".
Measured: 4 month
Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)
The 'SES" is a 14-item measure consisting of statements that assess the client specific engagement with services. It will be rated on a four-point Likert scale (not at all / rarely / sometimes / most of the time) by the investigator. The total score ranges from min. 0 to a max. of 42. Higher scores indicate lower engagement.
Measured: 4 month
Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)
The 'Medication Adherence Rating Scale' (MARS) is a reliable and valid self-reporting tool for investigation of the compliance in psychiatric patients also recognizing the complexity of compliance behaviour. 10 questions on medication attitude have to be answered by 'yes' or 'no' (8 times 1= no and Yes = 0 and twice 1= no, Yes =1). Results will be descriptively summarized. Summarized results minimum 0: low medication adherence, maximum 10: high medication adherence.
Measured: 4 month
Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)
The 'CSQ-8" is a brief, self-administered method to monitor the consumer's satisfaction with services in outpatient psychotherapy, showing high internal consistency. It is identified as a core subset of the general CSQ covering 8 Likert-type items with four response choices where '1' indicates the lowest and '4' the highest degree of satisfaction.
Measured: 4 month
Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Cost by Number of Days With Hospitalization
Any hospitalisation days in inpatients units and emergency ward stays will be recorded. At each hospitalisation, the number of days will be computed and at each visit, the cumulative total number of days will be used to calculate total costs. As higher the number of hospitalisation days as higher the costs per patient.
Measured: 4 month
Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Number of Days the Patient Was Not Able to Work or go to School or Complete Routine Daily Activities
The number of lost work days, lost school days or days without completing routine daily activities will be evaluated. With any number of lost workdays or lost school days or without completing routine daily activities, the costs will increase and the productivity will decrease.
Measured: 4 month
Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Need for Any Additional Antipsychotic Medication
Concomitant psychotropic drugs will be coded (ATC = Drug code) to allow a comparison of the number of drugs used per ATC class and per treatment visit. The drugs used will be listed by keeping their brand name for allowing to translate them into costs.
Measured: 4 month
Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference
Measuring of weight and waist circumference in centimeter.
Measured: 4 month
Evaluate Safety and Tolerability by Evaluation of Laboratory Tests
Measuring of: B-Haemoglobin (g/dl), B-Haematocrit(%), B-Erythrocyte count(pl), B-Leucocytes count (nl), B-Platelet count(nl), Complete blood count (nl), B-Leucocytes differential count (%), B-HbA1c(%), S-ALAT (U/l), S-ASAT (U/l), S-GGT (U/l), P-Glucose (fasting)(mh/dl), S-prolactin level (ng/ml), S-Pregnancy test (IU/l), Qualitative analysis of urine with Stix®,Urine pregnancy. Comparing results with standard values.
Measured: 4 month
Evaluate Safety and Tolerability by Evaluation of Concomitant Medication
Listing of all concomitant medication to show the efficacy and safety.
Measured: 4 month
Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events
Listing of all adverse event or SAE´s to show the safety and tolerability.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Difficulty finding eligible sites/patients; current situation in health policy cause negative effect on existing/planned contracts for integrated care program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Lambert, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681629
- Sponsor's protocol ID
- D1443L00048
- Acronym
- CARE II
- Status last verified
- Jun 2012
- First submitted
- 20 May 2008
- Last updated
- 30 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARE II - Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Phase IV Study
- ClinicalTrials.gov ID
- NCT00681629
- Acronym / sponsor ID
- CARE II / D1443L00048
- Keywords
- Schizophrenia, Integrated Care, Quetiapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty finding eligible sites/patients; current situation in health policy cause negative effect on existing/planned contracts for integrated care program
- Enrolment
- 7 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Posted 30 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine XR Alone | Experimental | Drug: Quetiapine XROral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion |
| Quetiapine XR With Integrated Care Program (ICP) | Experimental | Drug: Quetiapine XR, Other: Integrated Care Program (ICP)Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with baseline SWN-K <=70
- Provision of signed informed consent
- Out-patients with schizophrenia, schizophreniform disorder or schizoaffective disorder, severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points
Key exclusion criteria (3 listed)
- Evidence of a clinical relevant disease, eg renal or hepatic impairment, significant coronary heart disease, hepatitis B or C, AIDS
- Patients with known cardiovascular disease or other condition predisposing to hypotension or family history of QT prolongation
- Patients who pose an imminent risk of suicide or danger to self or others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine XRAlso: Seroquel Prolong400-800 mg, oral, bid | Drug | Quetiapine XR Alone, Quetiapine XR With Integrated Care Program (ICP) |
| Integrated Care Program (ICP)Integrated care program (ICP), this is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance. | Other | Quetiapine XR With Integrated Care Program (ICP) |
Primary outcome
Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale
Time frame: 4 months
The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.
19 secondary outcomes
Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score
Time frame: 4 month
Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale
Time frame: 4 month
Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score
Time frame: 4 month
GAF (Global Assessment of Functioning) Scale Score
Time frame: 4 month
PSP (Personal and Social Performance) Scale Score
Time frame: 4 month
EQ-5D (European Quality of Life Questionnaire) Score
Time frame: 4 month
Vocational Occupational Index "VOC" Score
Time frame: Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18)
Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire
Time frame: 4 month
Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale
Time frame: 4 month
Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)
Time frame: 4 month
Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)
Time frame: 4 month
Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)
Time frame: 4 month
Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Cost by Number of Days With Hospitalization
Time frame: 4 month
Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Number of Days the Patient Was Not Able to Work or go to School or Complete Routine Daily Activities
Time frame: 4 month
Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Need for Any Additional Antipsychotic Medication
Time frame: 4 month
Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference
Time frame: 4 month
Evaluate Safety and Tolerability by Evaluation of Laboratory Tests
Time frame: 4 month
Evaluate Safety and Tolerability by Evaluation of Concomitant Medication
Time frame: 4 month
Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events
Time frame: 4 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Lambert, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine XR and Integrated Care Program (ICP) in people with Schizophrenia and Schizoaffective Disorder, run by AstraZeneca at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.